1. Field of the Invention
Pharmaceutical entities use dry granulated material for forming tablets. This powder needs to flow smoothly and uniformly during compaction to facilitate forming of pharmaceutical tablets from the compressed material. Dry granulation is the preferred system since it is an in line process, and is not processed in batches. Instead it is a continuously occurring process which can be monitored. This process provides significantly greater product control. Also such processes minimize gaseous emissions that could otherwise be problematic. Furthermore, there are no solvents which provide various environmental problems. Also, other prior art systems are more complicated, and for this reason, pharmaceutical companies have settled on dry granulate as the preferred material from which tableting is performed. Also, such dry granulate processing is more easily adapted for use when forming products which have some level of moisture sensitivity.
2. Description of the Prior Art
Current prior art systems and apparatus have significant problems with dry granulation and roller compaction systems. In particular, there is very poor control of smoothness of flow, powder leveling and pressure distribution. This inaccurate control often results in uneven compressing or excessive compressing which reduces the recompressability of the product. Also under compressing presents an entirely different set of problems wherein the final product is not granules, but actual dust due to the lack of sufficient compression. Roller compaction produces a product which can be uneven and, therefor, needs to be accurately controlled in order to provide a compressed material which is capable of generating homogeneous tablets regularly.
In the prior art there is no accurate means for allowing full measurement and control of compacting pressure and distribution. The apparatus of the present invention provides this control by utilizing dynamically control side seals which can be moved at speeds different from the speeds of the rollers and, in some applications, different from one another. Also venting enhances the compaction process. Monitoring of compaction parameters further enhances the uniformity of the final compressed material.
As such, it is seen that the current state of the art shows a need for monitoring and feedback of the product in order to monitor the parameters of the process and to control the process, and as a result, the quality of compacted material varies widely and greatly. Many machine designs have been made for the purpose of testing, however, these normally are small quantity test materials, and the results are often not reproducible or predictable when scaled up to a full size machine usable in a production line. In particular, material that may have failed in the roller compaction process may work well where better controls of the compaction process are used for measurement and monitoring and feedback.
Many patents have been designed for the purposes of roller compaction or monitoring roller compaction technology such as shown in U.S. Pat. No. 3,730,659 patented May 1, 1973 to Joseph E. Smith and George D. DeTroyer and assigned to Wolverine-Pentronix, Inc. on a “Powder Dispenser For A Powder Compacting Press”; and U.S. Pat. No. 3,734,659 patented May 22, 1973 to Leroy S. Harris and assigned to K-G Industries Inc. on a “Drive Means For Material Compacting Apparatus”; U.S. Pat. No. 3,890,080 patented Jun. 17, 1975 to Ronald F. Cotts and assigned to IU Conversion Systems, Inc. on a “Roll-Pelletizer For Making Uniform Particle Size Pellets”; and U.S. Pat. No. 4,111,626 patented Sep. 5, 1978 to Yoshiro Funakoshi et al and assigned to Takeda Chemical Industries Ltd. on a “Powder Compacting Machine”; and U.S. Pat. No. 5,066,441 patented Nov. 19, 1991 to Thomas W. Gerard and assigned to Rhone-Poulenc Basic Chemicals Co. on a “Process For Compacting A Calcium Phosphate Composition”; and U.S. Pat. No. 5,515,740 patented May 14, 1996 to Ernesto Gamberini and assigned to MG2 S.p.A. on an “Apparatus For Dosing A Pharmaceutical product Into Capsules”; and U.S. Pat. No. 5,517,871 patented May 21, 1996 to Tapio Pento and assigned to Tensor Oy on a “Procedure For Simulating Tablet Compression”; and U.S. Pat. No. 5,596,865 patented Jan. 28, 1997 to Norbert Kramer on a “Method For The Removal And The Further Processing Of Tablets Or Pills Or The Like Derived From A Tablet Press And A Device For Performing The Method”; and Reissue Pat. Re. 35,506 patented May 13, 1997 to MIchael C. Solazzi et al and assigned to Chemplex Industries Inc. on a “Power Compacting Press Apparatus and Methods”; and U.S. Pat. No. 5,648,610 patented Jul. 15, 1997 to Ensio Laine et al on a “Method And Apparatus For The Characterization And Control Of Powder Compaction”; and U.S. Pat. No. 5,661,249 patented Aug. 26, 1997 to Michael Rupp et al and assigned to Walter Grassle GmbH on an “Apparatus And Method For Inspecting Small Articles”; and U.S. Pat. No. 5,671,262 patented Sep. 23, 1997 to Joseph H. Boyer et al on a “Method For Counting And Dispensing Tablets, Capsules, And Pills”; and U.S. Pat. No. 5,678,166 patented Oct. 14, 1997 to Henry R. Piehler et al and assigned to Henry R. Piehler on a “Hot-Triaxial Compaction”; and U.S. Pat. No. 5,796,051 patented Aug. 18, 1998 to Franco Chiari et al and assigned to Macofar S.p.A. on a “Process For In-Line Capsule Check Weighting And The Apparatus Which Allows The Process To Be Implemented”; and U.S. Pat. No. 5,958,467 patented Sep. 28, 1999 to Herbert Dale Coble et al and assigned to Glaxo Wellcome Inc. on an “Exit Chute For Pharmaceutical Tablet Press Machine”; and U.S. Pat. No. 5,971,038 patented Oct. 26, 1999 to Jurgen Fiedler et al and assigned to KORSCH Pressen GmbH on a “Process And Device For Checking The Tablet Parameters”; and U.S. Pat. No. 5,989,487 patented Nov. 23, 1999 to Sang H. Yoo et al and assigned to Materials Modification, Inc. on an “Apparatus For Bonding A Particle Material To Near Theoretical Density”; and U.S. Pat. No. 6,001,304 patented Dec. 14, 1999 to Sang H. Yoo et al and assigned to Materials Modification, Inc. on a “Method Of Bonding A Particle Material To Near Theoretical Density”; and U.S. Pat. No. 6,079,284 patented Jun. 27, 2000 to Taizo Yamamoto and assigned to Shinogi Qualicaps Co., Ltd. on a “Visual Inspection Apparatus For Tablets”; and U.S. Pat. No. 6,106,262 patented Aug. 22, 2000 to Michael Levin et al and assigned to Metropolitan Computing Corporation on a “Press Simulation Apparatus”; and U.S. Pat. No. 6,183,690 patented Feb. 6, 2001 to Sang H. Yoo et al and assigned to Materials Modification, Inc. on a “Method Of Bonding A Particle Material To Near Theoretical Density”; and U.S. Pat. No. 6,187,087 patented Feb. 13, 2001 to Sang H. Yoo et al and assigned to Materials Modification, Inc. on a “Method Of Bonding A Particle Material To Near Theoretical Density”; and U.S. Pat. No. 6,234,744 patented May 22, 2001 to Don Cawley and assigned to Sage Automation, Inc. on a “Robotic Palletizing System”; and U.S. Pat. No. 6,257,079 patented Jul. 10, 2001 to Werner G. Mueller and assigned to Erweka GmbH on a “Tablet Testing Appliance”; and U.S. Pat. No. 6,260,419 patented Jul. 17, 2001 to Norbert Kramer on a “Method And Device For Conducting A Hardness Test On Test Specimens, Especially Tablets Or Pills”; and U.S. Pat. No. 6,270,718 patented Aug. 7, 2001 to Sang H. Yoo et al and assigned to Materials Modification, Inc. on a “Method Of Bonding A Particle Material To Near Theoretical Density”; and U.S. Pat. No. 6,482,338 patented Nov. 19, 2002 to Michael Levin et al and assigned to Metropolitan Computing Corporation on a “Press Simulation Apparatus And Methods”.